In South Africa, antiretroviral therapy (ART) has transformed HIV into a chronic, manageable condition, with high rates of viral suppression. As people living with HIV (PLWH) live longer, HIV care is increasingly focused on long-term health, quality of life, and prevention of non-communicable diseases such as obesity,cardiovascular disease, and metabolic disorders, which are increasingly common in this population. Sleep disturbance is highly prevalent among PLWH but is under-recognised in routine care. Poor sleep has been associated with adverse cardiometabolic, cognitive, and functional outcomes, yet is rarely systematically assessed in HIV programmes. Most existing evidence relies on subjective measures, with limited objective polysomnography data, particularly in African populations. In addition, the impact of different ART regimens on sleep health remains poorly understood. This study aims to evaluate and compare sleep health in virologically suppressed PLWH who switch from a dolutegravir-based regimen to a doravirine-based regimen versus thosewho remain on dolutegravir-based therapy. Sleep will be assessed using a multidimensional approach, incorporating polysomnography, actigraphy, and validated patient-reported outcome measures aligned with the RU-SATED framework. The study is particularly relevant in South Africa, where dolutegravir-based regimens are widely used and where obesity and metabolic disease are increasing. In a resource-limited setting where sleep disorders are often underdiagnosed, this study will generate locally relevant evidence on the relationship between ART and sleep health, with potential implications for more holistic HIV care.
Male or female aged 18-40 years
HIV-positive
Virologically suppressed, defined as HIV RNA <50 copies/mL
No known history of HIV treatment failure
Planned or recent (30 days before enrolment) changes to chronic medication, or anticipated medication changes during the study period, if applicable
Known contraindication to Delstrigo (hepatic impairment, hypersensitivity, strong CYP450 inducers)
Previous NNRTI use or prior documented NNRTI mutations
Clinical suspicion of TB
Parallel
Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Doravirine 100mg
DrugDELSTRIGO is a three-drug combination of doravirine (a non-nucleoside reverse transcriptase inhibitor \[NNRTI\]), lamivudine, and tenofovir disoproxil fumarate (both nucleoside analogue reverse transcriptase inhibitors) and is indicated as a complete regimen for the treatment of HIV infection in adults and adolescent individuals weighing at least 35 kg. One tablet contains 100 mg of doravirine, 300 mg of lamivudine, and 300 mg of tenofovir disoproxil fumarate. Participants will be required to take one tablet PO daily for the duration of the study.
Tenofovir disoproxil fumarate 300mg / Lamivudine 300mg / Dolutegravir 50mg
DrugTenofovir disoproxil fumarate 300mg /lamivudine 300mg /dolutegravir 50mg (fixed dose combination tablet) one tab taken orally daily for the duration of the study.
Change in RU-SATED total score from baseline to week 12
RU-SATED Questionnaire (Total Score: 0-24) Sleep health will be assessed using the RU-SATED sleep health questionnaire, a validated multidimensional measure comprising six domains of sleep health: Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration. Each domain is scored on a scale of 0-4, with higher scores indicating better sleep health. The total score ranges from 0 to 24, with higher scores reflecting overall better sleep health. The six items are as follows: Regularity: I go to sleep and wake up at about the same time every day. Duration: I sleep 7-9 hours per night. Timing: The midpoint of my sleep period is between 2:00 a.m. and 4:00 a.m. Efficiency: I am awake for less than 30 minutes between the time I go to bed and the time I get out of bed. Alertness: I stay awake all day without dozing. Satisfaction: I am satisfied with my sleep.
Between-Arm Difference in RU-SATED Total Sleep Health Score at Week 12
The RU-SATED questionnaire will be used to assess multidimensional sleep health across six domains: Regularity, Satisfaction, Alertness, Timing, Efficiency, and Duration. Each domain is scored from 0 to 4, with higher scores indicating better sleep health. The total RU-SATED score ranges from 0 to 24, with higher scores indicating better overall sleep health. Between-arm differences will compare mean RU-SATED total scores between participants switching from DTG-based ART to DOR-based ART and those continuing DTG-based ART at Week 12.
Change from Baseline to Week 12 in Polysomnography-Derived Sleep Stage Distribution (N1, N2, N3, REM)
Sleep architecture will be assessed using overnight polysomnography (PSG). Sleep stage distribution (N1, N2, N3, and REM) will be expressed as percentage of total sleep time.
Change from Baseline to Week 12 in Polysomnography-Derived Sleep Latency
Sleep latency will be measured using overnight PSG and defined as the time from lights-off to sleep onset
Change from Baseline to Week 12 in Polysomnography-Derived REM Latency
REM latency will be measured using overnight PSG and defined as the time from sleep onset to the first epoch of REM sleep
Internal consistency of the RU-SATED questionnaire measured by Cronbach's alpha
Preliminary psychometric evaluation of the RU-SATED questionnaire will be conducted, including internal consistency reliability (e.g., Cronbach's alpha).
Correlation between RU-SATED score and PROMIS Sleep Disturbance SF 8a
Convergent validity assessed via Spearman correlations between RU-SATED and PROMIS SD SF 8a
Sleep Duration Measured by Actigraphy at Baseline and Week 12
Actigraphy will be used to characterise habitual sleep patterns in the study cohort, including estimates of total sleep time.
Sleep Efficiency Measured by Actigraphy at Baseline and Week 12
Actigraphy will be used to characterise habitual sleep patterns in the study cohort, including sleep efficiency.
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